Associate Director, R&D IT (CF-33927683)
Functional Job Responsibilities
* Is responsible for Japan R&D IT stakeholder management, budget (Financial Cycle Planning and estimate), and to support the portfolio/programs/project financial management. This role will strengthen IT core operations across the Asia affiliates to ensure stable, secure systems/solutions that optimize efficiency to enable and drive the business demands and needs.
* Capability and capacity based financial planning for R&D IT technology investment projects, sustainment, and operational activities for R&D business areas (Regulatory Affairs, Patient Safety, Medical Affairs and Clinical Operations) focusing on key business capabilities within Japan affiliate. This role will be responsible for working with business team to deliver best in-class and innovative solutions for business capabilities, partnering with our R&D IT technical team and liaising with our Japan commercial IT team.
* Act as single point of contact and escalation for R&D business stakeholders in Japan affiliate to understand, evaluate, analyse and execute business demands and needs by liaising with global R&D IT and other IT teams to successfully meet and deliver business capabilities through technology solutions.
* Is responsible for ensuring that the local Japan affiliate R&D systems operate smoothly and to help and direct the IT and external vendors to support operational excellence for the R&D business stakeholders in Japan. * Act as single point of contact for PMs across R&D IT projects/programs/portfolio focusing on Japan affiliate requirements to ensure strict compliance of processes, standards, and timelines to enable strategic partners to deliver business value.
* Expert level knowledge of enterprise demand management lifecycle from demand intake to execution across Agile and waterfall methodologies using continuous improvement methodologies.
* Expert level hands on knowledge in process improvements across the portfolio in terms of yearly planning cycles, project submission requests based on organizational submission cadence.
* Is responsible for Inspection Readiness - Japan and Asia affiliates inspections and internal/external audits from R&D IT team, work with global R&D IT team to support designing an inspection playbook and working closely with Regulatory Compliance team, Infrastructure IT team and R&D IT team SMEs for alignment and resource planning across all functional domains within R&D IT for HA inspections, audits, inspection summary, and IT actions.
* Is responsible as Business Engagement lead for our Mergers, Acquisitions, and collaborations within the Asia affiliates from R&D IT perspective, working closely with senior IT and business management, IT infrastructure, security, and M&A team to plan, collaborate and execute a smooth onboarding of new personnel, systems, and processes as appropriate.
* Travel to Asia (e.g. China, Hong Kong, Singapore) affiliates to meet the business stakeholders and IT team in-person for strategic planning, stakeholder management and technology roadmap projects as required.
Knowledge, Experience & Skills:
* Bachelor's Degree and significant experience OR Masters' Degree and substantial experience.
* Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferred.
* Good understanding of GxP compliance and 21 CFR Part 11 requirements.
* Expert level expertise in R&D (Regulatory Affairs, Safety, Medical Affairs and Clinical Operations) domain - business and technology processes, GxP change management, VeeVa RIM, Adverse Events management, PromoMats suite, submissions planning, registrations, archiving, document management, Medical information systems and Signal detection and management.
* Familiar with VeeVa Vault platform, Argus suite, Salesforce, Lorenz docuBridge, Insight suite, AWS, MS Project or similar, Azure Dev/Ops and RPA (Robotic Process Automation) as a welcomed addition.
* Hands on expertise in Agile/Scrum/Waterfall planning and execution of portfolios across all demands and request life cycles.
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Award winner of:
Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best IT & Technology Recruitment Company of the Year by Recruitment International Awards 2018